Oral appliance device

ABSTRACT

An oral appliance device that selectively engages upper teeth and lower teeth within a human mouth includes an upper appliance member, a lower appliance member, and a first vertical shim. The upper appliance member selectively engages the upper teeth. The lower appliance member selectively engages the lower teeth. The appliance members are movable relative to one another between an open position and a closed position. The first vertical shim is removably secured to one of the appliance members. The first vertical shim has a first shim height so that a teeth spacing between the upper teeth and the lower teeth is maintained when the appliance members are in the closed position. The teeth spacing is at least as great as the first shim height. The oral appliance device can further include a second vertical shim that is alternatively, removably secured to one of the appliance members. The second vertical shim has a second shim height that is different than the first shim height.

RELATED APPLICATIONS

The present application is a continuation-in-part application claimingthe benefit under 35 U.S.C. 120 on co-pending U.S. patent applicationSer. No. 15/990,544, filed on May 25, 2018, and entitled “SYSTEMS,METHODS AND ORAL APPLIANCE DEVICES”. Additionally, U.S. patentapplication Ser. No. 15/990,544 claims priority on U.S. ProvisionalApplication Ser. No. 62/511,902, filed on May 26, 2017, and entitled“SYSTEMS, METHODS AND ORAL APPLIANCE DEVICES”. As far as permitted, thecontents of U.S. patent application Ser. No. 15/990,544 and U.S.Provisional Application Ser. No. 62/511,902 are incorporated herein byreference.

BACKGROUND

Upper airway issues impacting respiration, including upper airwayresistance, affect millions of individuals worldwide, and can causeserious medical consequences for the individual. Additionally, suchupper airway issues may also cause sleep disruption issues for theindividual, such as in the form of snoring, hypopnea and sleep apnea.

Hypopnea is a condition characterized by shallow breathing or anabnormally low respiratory rate resulting in reduced air flow. Sleepapnea is a condition characterized by a temporary cessation of breathingthat can result in complete cessation of air flow and thus suffocation.These upper airway issues can create conditions requiring the body ofthe affected individual to expend more effort than usual in order toovercome the reduced airflow. This can result in a fragmentation ofsleep patterns due to awakening for short or extended periods of time.As such, these conditions often limit an individual's ability to enterdeeper sleep stages that serve the vital function of refreshing andrestoring the sleeping individual, and are also damaging to many vitalbodily systems and functions.

Additionally, temporomandibular joint and muscle disorders, commonlyreferred to as “TMJ”, are known to cause sleeping problems and can bethe cause of craniofacial pain in both children and adults. Varioussymptoms are associated with craniofacial pain including recurring andchronic headaches; earaches; ear stuffiness or ringing; neck pain orstiffness; facial pain; jaw joint clicking, popping or grating; limitedability to open or close the mouth; jaw locking in either open or closedpositions; sensitive, loose or worn down teeth; pain or soreness in thetemporomandibular joint; dizziness; pain or difficulty chewing orswallowing; pain behind the eyes; extreme sensitivity to light;attention-deficit hyperactivity disorder (ADHD); bed wetting and others.

Various methods of treatment have been developed as a means to addresssleep disruption issues such as snoring, hypopnea and sleep apnea, aswell as a means to address issues such as TMJ. For example, one devicecommonly used for treatment of such issues is referred to as aContinuous Positive Air Pressure (CPAP) device. Such devices deliverpressurized air from a pumping component through a hose and into a maskthat is secured over the nose of the individual. Unfortunately, CPAPdevices have been unsuccessful for a growing number of patients due todiscomfort while using the device, lifestyle issues, and portabilityproblems associated with the device when the individual travels.

Additionally, certain surgical techniques are also available to addresssuch issues for the individual. Unfortunately, such surgical techniquessuffer drawbacks such as high costs, lack of reversibility, risk ofharm, e.g., permanent physical damage, to the individual, and extensiveand often painful recovery periods.

Further, various types of non-invasive devices have also been developedin an attempt to alleviate or eliminate such issues for the individual.Some such devices focus on improving airflow through the nose, with somedevices being attached to the external skin on either side of the nose,and other devices being designed to fit within the nasal passageway andpush the inner walls of the nose outward to expand the air passageways.Unfortunately, such devices can irritate the skin and/or can irritatethe sensitive inner lining of the nasal passageway, thereby making suchdevices uncomfortable and awkward to use.

Other such devices focus on repositioning the lower jaw or mandible inan anterior or forward position. This orientation can pull the base ofthe tongue forward within the mouth and thereby increase the size of theair passage in the posterior pharyngeal region, which is the breathingpassage behind the base of the tongue. Some such devices arenon-adjustable devices, and thus may not be appropriate if there is achange in the position of the lower jaw relative to the upper jaw. Othersuch devices are adjustable devices, but they typically take up morespace within the mouth and restrict tongue space which can inhibit thetongue from moving forward as desired. Such devices may also adverselyimpact the ability of the individual to close their lips, which can makethe device uncomfortable to wear and inhibit the individual's ability tochange positions during sleep.

Due to the varied nature of symptoms and potential negative resultscaused by snoring, hypopnea, sleep apnea, and TMJ, it is desirable totreat these conditions using a non-invasive apparatus that does notsuffer the drawbacks and disadvantages of current devices.

SUMMARY

The present invention is directed toward an oral appliance device foruse within a human mouth. In various embodiments, the oral appliancedevice includes an upper appliance member, a lower appliance member, anda first vertical shim. The upper appliance member selectively engagesupper teeth within the human mouth. The lower appliance memberselectively engages lower teeth within the human mouth. The appliancemembers are movable relative to one another between an open position anda closed position. The first vertical shim is removably secured to oneof the appliance members. The first vertical shim has a first shimheight so that a teeth spacing between the upper teeth and the lowerteeth is maintained when the appliance members are in the closedposition. The teeth spacing is at least as great as the first shimheight.

In some embodiments, the oral appliance device further includes a secondvertical shim that is alternatively, removably secured to one of theappliance members. The second vertical shim has a second shim height sothat the teeth spacing between the upper teeth and the lower teeth ismaintained when the appliance members are in the closed position, theteeth spacing being at least as great as the second shim height. Incertain such embodiments, the first shim height is different than thesecond shim height. Thus, the healthcare professional and/or the patientare able to create an appropriate or desired teeth spacing between theupper teeth and the lower teeth by selecting an appropriate verticalshim.

Additionally, in certain embodiments, the first vertical shim isremovably secured to the upper appliance member. The oral appliancedevice further includes a second vertical shim that is removably securedto the lower appliance member. The second vertical shim has a secondshim height so that the teeth spacing between the upper teeth and thelower teeth is maintained when the appliance members are in the closedposition. In such embodiments, the teeth spacing is at least as great asthe first shim height plus the second shim height. As such, the heightsof each of the first vertical shim and the second vertical shim can becombined to provide another desired teeth spacing between the upperteeth and the lower teeth. It is appreciated that the appropriatevertical shim(s) in any given situation can be chosen and usedindividually or in combination with other vertical shims to provide anydesired and/or suitable teeth spacing between the upper teeth and thelower teeth.

In some embodiments, the one of the appliance members includes a shimreceiver that is configured to removably receive and retain a portion ofthe first vertical shim for removably coupling the first vertical shimto the one of the appliance members. Additionally, in such embodiments,the first vertical shim can include an appliance engager that isintegrally formed with the first vertical shim. With such design, theshim receiver is configured to removably receive and retain theappliance engager of the vertical shim. In one embodiment, the applianceengager rotatably engages the shim receiver such that the first verticalshim is movable between a disengaged configuration wherein the firstvertical shim can be selectively secured or coupled to and removed fromthe one of the appliance members, and an engaged configuration, whereinwhen in the engaged configuration the first vertical shim cannot beremoved from the one of the appliance members. Further, in oneembodiment, the appliance engager includes at least one post thatextends away from a shim surface of the first vertical shim; and whereinthe shim receiver includes at least one aperture formed into a membersurface of the one of the appliance members, the at least one aperturebeing sized and shaped to receive the at least one post.

Additionally, in certain embodiments, the first vertical shim is formedfrom a nylon-based material. For example, the first vertical shim can beformed from PA 2200 nylon and/or polyamide 12 nylon. Further, in suchembodiments, the first vertical shim can be manufactured using one of athree-dimensional printer and a selective laser sintering process. Stillfurther, in some such embodiments, the upper appliance member and thelower appliance member can also be formed from a nylon-based material.

Additionally, the present invention is further directed toward an oralappliance device for use within a human mouth, the oral appliance deviceincluding an upper appliance member that selectively engages upper teethwithin the human mouth; a lower appliance member that selectivelyengages lower teeth within the human mouth; a first vertical shim thatis removably secured to one of the appliance members, the first verticalshim having a first shim height; and a second vertical shim that isremovably secured to one of the appliance members, the second verticalshim having a second shim height that is different than the first shimheight.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of this invention, as well as the invention itself,both as to its structure and its operation, will be best understood fromthe accompanying drawings, taken in conjunction with the accompanyingdescription, in which similar reference characters refer to similarparts, and in which:

FIG. 1 is a simplified front view illustration of a human mouth and anembodiment of an oral appliance device having features of the presentinvention that is positioned within the mouth;

FIG. 2A is a simplified side view illustration of an embodiment of theoral appliance device;

FIG. 2B is a partially exploded view illustration of a portion of theoral appliance device illustrated in FIG. 2A;

FIG. 2C is a partially exploded view illustration of another portion ofthe oral appliance device illustrated in FIG. 2A;

FIG. 3A is a simplified side view illustration of another embodiment ofthe oral appliance device;

FIG. 3B is a partially exploded view illustration of the oral appliancedevice illustrated in FIG. 3A;

FIG. 4A is a simplified perspective view illustration of still anotherembodiment of the oral appliance device;

FIG. 4B is a simplified top view illustration of a portion of the oralappliance device illustrated in FIG. 4A;

FIG. 4C is a partially exploded view illustration of a portion of theoral appliance device illustrated in FIG. 4A;

FIG. 5A is a simplified top perspective view illustration of anotherembodiment of the oral appliance device;

FIG. 5B is a partially exploded view illustration of the oral appliancedevice illustrated in FIG. 5A;

FIG. 6A is a simplified front view illustration of a portion of yetanother embodiment of the oral appliance device;

FIG. 6B is a top perspective view illustration of the portion of theoral appliance device illustrated in FIG. 6A;

FIG. 6C is a simplified side view illustration of the portion of theoral appliance device illustrated in FIG. 6A;

FIG. 7A is a simplified side view illustration of still yet anotherembodiment of the oral appliance device; and

FIG. 7B is an exploded view illustration of a portion of the oralappliance device illustrated in FIG. 7A.

DESCRIPTION

Embodiments of the present invention are described herein in the contextof an oral appliance device. In particular, as described in detailherein, various embodiments of the oral appliance device are uniquelydesigned and/or are uniquely formed to overcome and/or inhibit upperairway issues from causing sleep disruption issues for an individual,such as in the form of snoring, hypopnea and sleep apnea. For example,as provided herein, the oral appliance device can incorporate a modulardesign with removable and/or exchangeable components, which uses uniquematerials and/or manufacturing processes that can provide variousbenefits and advantages for the patients using the oral appliance deviceas well as the healthcare professionals providing such devices, incomparison to traditional oral appliance devices. Additionally, in someembodiments, the oral appliance device can provide a nasal and lingualbreathing aid that acts intraorally and can be fixed in place byselective attachment to the oral appliance device (or removed) dependingon patient compatibility. Further, embodiments of the oral appliancedevice are further usable to overcome and/or inhibit temporomandibularjoint and muscle disorders, i.e. TMJ, which can also cause sleepingproblems and/or be the cause of craniofacial pain in the individual.

Those of ordinary skill in the art will realize that the followingdetailed description of the present invention is illustrative only andis not intended to be in any way limiting. Other embodiments of thepresent invention will readily suggest themselves to such skilledpersons having the benefit of this disclosure. Reference will now bemade in detail to implementations of the present invention asillustrated in the accompanying drawings. The same or similarnomenclature and/or reference indicators will be used throughout thedrawings and the following detailed description to refer to the same orlike parts.

In the interest of clarity, not all of the routine features of theimplementations described herein are shown and described. It will, ofcourse, be appreciated that in the development of any such actualimplementation, numerous implementation-specific decisions must be madein order to achieve the developer's specific goals, such as compliancewith application-related and business-related constraints, and thatthese specific goals will vary from one implementation to another andfrom one developer to another. Moreover, it will be appreciated thatsuch a development effort might be complex and time-consuming, but wouldnevertheless be a routine undertaking of engineering for those ofordinary skill in the art having the benefit of this disclosure.

FIG. 1 is a simplified front view illustration of a human mouth 10 (alsoreferred to herein simply as a “mouth”) including a plurality of teeth11, and an embodiment of an oral appliance device 12 having features ofthe present invention that is positioned within the mouth 10. Moreparticularly, as shown, the oral appliance device 12 is positioned toselectively engage the plurality of teeth 11 within the mouth 10.

As noted, the mouth 10 can include a plurality of teeth 11, i.e. aplurality of upper teeth 11A and a plurality of lower teeth 11B. Alsoshown in FIG. 1, the mouth 10 can further include interior features suchas the buccal sulcus 13. There are four buccal sulcus 13 in the mouth 10and each is known generally as a depression having a width extendingbetween a cheek and an alveolar process of the arch, where the arch isknown as the composite structure of the teeth. Each buccal sulcus 13begins at a buccal frenum toward the front of the mouth 10 and extendsto the back of the mouth 10. As such, each buccal sulcus 13 is orientedgenerally front to back in the mouth 10 above and outside the teeth 11and inside the gums.

It is appreciated that when determining the most effective patienttreatment, a healthcare professional may need to capture oral or otherimpressions of the patient's face and head. For example, an accurateimpression of the buccal sulcus 13 can be essential for the correctpositioning of nasal dilators (i.e. for dilating a nasal passage (notshown)), tongue positioners (i.e. for affecting the positioning of atongue 15 within the mouth 10), jaw positioners (i.e. for controlling arelative position between an upper jaw 17A and a lower jaw 17B withinthe mouth 10) and/or other components which may be required in patienttreatment in order to open the patient's airway. Unfortunately, thisarea can be difficult to capture with impressions, especially digitalimpressions due to its location and discomfort to the patient. However,without an accurate impression, a dental laboratory would find itextremely difficult or impossible to fabricate a therapeutic oralappliance device with proper function. Current oral appliance systemsused for capturing digital impressions are generally unitary, andtherefore not adjustable. As such, if a doctor or dentist wishes toadjust the oral appliance device to a different position, the entireoral appliance device must be sent to the dental laboratory to have theincorrect modification removed and a replacement fabricated. The patientis rarely present at the laboratory when the adjustments are being madeto the replacement device. As such, the laboratory will estimate orguess what position the nasal dilator and/or other components should beplaced to provide the most effective and comfortable treatment. If thelaboratory is incorrect in their assessment, the process of sending itfrom the dental practice back to the dental laboratory will repeatleading to patient and staff frustration.

Thus, a modular system that allows a doctor, dentist or other healthcareprofessional to freely remove, change or adjust such componentsassociated with the oral appliance device 12 into a functional position,as described in detail herein, without sending the entire system to alaboratory for re-fabrication would provide the best patient careoutcome without cause for lapse in conditions. Accordingly, variousembodiments of the oral appliance device 12, as described herein,include a modular design that can more effectively and efficientlyresult in reduced costs, saved time, improved comfort, convenience andfunctionality, and a more effective overall patient treatment. Further,various embodiments disclosed herein provide oral appliance devices 12which are less bulky, more durable, and which are contained solelywithin the oral cavity.

The design of the oral appliance device 12 can be varied to suit theparticular patient as well as the particular issues to be addressed. Invarious embodiments, as shown in FIG. 1, the oral appliance device 12can include an upper appliance member 14 that is configured toselectively engage and/or be secured or coupled to the upper teeth 11A,and a lower appliance member 16 that is configured to selectively engageand/or be secured or coupled to the lower teeth 11B. Additionally, insome embodiments, the oral appliance device 12 can further include aconnector assembly 18 for selectively and movably connecting the upperappliance member 14 and the lower appliance member 16 to one another.Further, as illustrated, the oral appliance device 12 can also include ateeth spacing assembly 20 that is configured to selectively adjustand/or maintain a teeth spacing 21 between the upper teeth 11A and thelower teeth 11B within the mouth 10. As utilized herein, the “teethspacing” between the upper teeth 11A and the lower teeth 11B that isadjusted and/or maintained through the use of the teeth spacing assembly20 is the spacing between the upper teeth 11A and the lower teeth 11Bthat is caused solely by components of the oral appliance device 12 andnot by relative movement between the teeth 11A, 11B and appliancemembers 14, 16 created by voluntary movements of the mouth 10 and teeth11 of the patient.

It is appreciated that the oral appliance device 12 can include morecomponents or fewer components than those specifically shown in FIG. 1.For example, as described in greater detail herein below, in certainembodiments, the oral appliance device 12 can also include one or moreof (i) a nasal dilator assembly 422 (illustrated in FIG. 4A) that opensup the nasal passageway while not irritating or acting as an obtrusiveobject in the buccal sulcus 13, (ii) a tongue positioner assembly 524(illustrated in FIG. 5A) that helps to maintain maximum intraoral tonguespace in comparison to previous oral appliance devices, (iii) a jawposition controller 626 (illustrated in FIG. 6A, and also sometimesreferred to herein as a “jaw positioner”) that can function as amandibular stop, thus inhibiting the lower jaw 17B from falling back ina supine position, and therefore inhibiting collapse of the airway, and(iv) a Herbst device assembly 728 (illustrated in FIG. 7A) that can alsocontrol the positioning of the lower jaw 17B so as to inhibit the lowerjaw 17B from falling back and potentially blocking the upper airway ofthe individual. It is also appreciated that the connector assembly 18,the teeth spacing assembly 20, the nasal dilator assembly 422, thetongue positioner assembly 524, the jaw position controller 626, and theHerbst device assembly 728 can be used individually or in any suitablecombination within any given embodiment of the oral appliance device 12.Additionally, or in the alternative, it is further appreciated thatindividual embodiments of the oral appliance device 12 need not includethe connector assembly 18 and/or the teeth spacing assembly 20.

As an overview, the oral appliance device 12 of the present invention isuniquely configured in various alternative embodiments to provideimproved airflow through nasal and pharyngeal air passages, thusovercoming and/or inhibiting issues within the upper airway of anindividual from causing sleep disruption issues for the individual,e.g., in the form of snoring, hypopnea and/or sleep apnea. It is furtherappreciated that such embodiments of the oral appliance device 12 canalso function to overcome and/or inhibit any potential issues withtemporomandibular joint and muscle disorders.

Additionally, as provided herein, the various components of the oralappliance device 12 can be formed from materials and/or formed from aunique process that can save time and money, as well as improvingoverall patient treatment options. For example, as described herein,various embodiments of the oral appliance device 12 and/or the specificcomponents included therewith can be formed from nylon-based materialssuch as PA2200 nylon, polyamide 12 nylon, or other suitable nylon-basedmaterials. Further, in many applications, the oral appliance device 12and/or the specific components included therewith can be created ormanufactured using a three-dimensional (3-D) printer or a selectivelaser sintering (SLS) process. With such processes, any components ofthe oral appliance device 12 can be quickly and easily made or remadewithout the need for additional models or impressions being formed,which can otherwise greatly slow down the overall treatment process.Additionally, in various embodiments, flexible printed material canallow less bulky fabrication of oral appliance devices 12 thanpreviously developed devices that are equal if not more durable thansuch previous oral appliance devices. Since these materials are lessbulky, they are better able to maintain the tongue 15 in a forwardposition while reducing airflow resistance through the pharyngealregion, thus preventing the tongue 15 from falling backward in a supineposition. This can be beneficial since the position of the tongue 15plays a large role in airway obstruction at rear positioned tongueregions.

Those in the art will recognize that patients who may misplace theirindividualized oral appliance device are able to have a new onefabricated quickly by a laboratory when using printed designs. Thisprovides the benefit of reduced or eliminated requirements for medicalprofessionals to create new records, saving time and money by improvingefficiency. This also provides the benefit of allowing for manufacturingof replacement oral appliance devices and/or the individual componentsthereof that are substantially identical to the originals withoutrequiring additional appointments to be scheduled or records to becreated. Thus, patients are provided optimal comfort with minimal timerequirements. Another benefit is the added advantage of time savings forhealthcare professionals in the form of a reduction in time required toadjust these oral appliance devices and their associated components,such as teeth spacers, nasal dilators, tongue positioners, jawpositioners, etc., when modifying or correcting positioning.

Based on the advantages of the modular designs disclosed herein, anydamaged or destroyed components for the oral appliance device 12 can bequickly and easily replaced in the office by the healthcareprofessional. This removes the need to send the oral appliance device 12back to a laboratory for adjustments. Thus, patients do not have tosuffer unnecessarily without their oral appliance devices. For example,if the patient is non-compliant, both the nasal dilators and tonguepositioners can be removed without lessening the integrity of the oralappliance device 12 and without causing discomfort to the patient.

FIG. 2A is a simplified side view illustration of an embodiment of theoral appliance device 212. As shown in this embodiment, the oralappliance device 212 includes the upper appliance member 214, the lowerappliance member 216, the connector assembly 218 and the teeth spacingassembly 220. In certain non-exclusive alternative embodiments, the oralappliance device 212 can further include one or more of the nasaldilator assembly 422 (illustrated in FIG. 4A), the tongue positionerassembly 524 (illustrated in FIG. 5A) and the jaw position controller626 (illustrated in FIG. 6A).

As provided above, during use of the oral appliance device 210, theupper appliance member 214 is positioned to selectively engage the upperteeth 11A (illustrated in FIG. 1) and the lower appliance member 216 ispositioned to selectively engage the lower teeth 11B (illustrated inFIG. 1).

In various embodiments, the upper appliance member 214 and/or the lowerappliance member 216 may provide a frame which other components, e.g.,components of the connector assembly 218 and/or components of the teethspacing assembly 220, can be permanently or removably secured with ormounted to. More specifically, the upper appliance member 214 isgenerally a casting mouthpiece of a patient's maximal, superior or upperdental arch. Additionally, the upper appliance member 214 can include acustom-molded mouthpiece that includes at least one flat occlusal, uppermember surface 214A (illustrated in FIG. 2B) that can be approximatelylocated below a portion of all of the area between a second bicuspid anda first molar along both extensions, arms, or sides of the upperappliance member 214 and positioned facing downward toward the inferior,mandibular or lower dental arch. As such, the flat occlusal, uppermember surface 214A can function as a posterior vestibular support pad,and which can provide the patient with occlusion that is free fromocclusal or other forces during operation.

Somewhat similarly, the lower appliance member 216 is generally acasting mouthpiece of a patient's mandibular, inferior or lower dentalarch. Additionally, the lower appliance member can be a custom-moldedmouthpiece that includes at least one flat occlusal, lower membersurface 216A (illustrated in FIG. 2C) along both extensions, arms orsides of the lower appliance member 216 and facing upward toward thesuperior, maximal or upper dental arch.

In certain embodiments, the upper appliance member 214 and the lowerappliance member 216 can be formed from any suitable materials and/orcan be formed from any suitable manufacturing process. For example, insome non-exclusive embodiments, the upper appliance member 214 and/orthe lower appliance member 216 can be formed from a nylon-basedmaterial, e.g., PA 2200 nylon, polyamide 12 nylon, or another suitablenylon material. Alternatively, the upper appliance member 214 and/or thelower appliance member 216 can be formed from other suitable materials.For example, in certain non-exclusive alternative embodiments, the upperappliance member 214 and/or the lower appliance member 216 can useappropriate and effective materials such as using a processed acrylicthat has a hard-molded outer shell and, optionally may include a softinner lining, to capture the patient's maximal dental arch and thepatient's mandibular dental arch, respectively. Manufacturing processesfor such alternative materials can include the use of “boil-and-bite”materials, pre-formed or pre-fabricated common arch forms, or otherprocesses and materials currently known in the art. In still otherembodiments, the upper appliance member 214 and/or the lower appliancemember 216 can be formed from a thermoplastic material, which can beheat molded over a dental model of the patient's teeth.

Additionally, in certain non-exclusive alternative embodiments, theupper appliance member 214 and/or the lower appliance member 216 can bemanufactured using one of a three-dimensional printer and a selectivelaser sintering process. With such design, the upper appliance member214 and the lower appliance member 216 can be quickly and easily made orremade from a single model without the need for additional impressionsor models. Alternatively, the upper appliance member 214 and/or thelower appliance member 216 can be manufactured using another suitableprocess.

As noted above, the connector assembly 218 is provided such that theupper appliance member 214 and the lower appliance member 216 can beselectively and movably connected to one another. This results in theupper appliance member 214 and the lower appliance member 216 being ableto be effectively utilized in conjunction with one another, and whilestill allowing the patient to move their upper teeth 11A (and upper jaw17A (illustrated in FIG. 1)), and their lower teeth 11B (and lower jaw17B (illustrated in FIG. 1)), relative to one another. Additionally, theconnector assembly 218 is further configured to inhibit the lower jaw17B from falling back in a supine position and potentially blocking theupper airway of the individual. In some embodiments, the connectorassembly 218 is configured to enable the upper appliance member 214 andthe lower appliance member 216 to move relative to one another and/or toallow for protrusive titration between the appliance members 214, 216 ofbetween approximately one millimeter and five millimeters.Alternatively, the connector assembly 218 can be configured to enablethe upper appliance member 214 and the lower appliance member 216 tomove relative to one another and/or to allow for protrusive titrationbetween the appliance members 214, 216 of less than approximately onemillimeter or greater than approximately five millimeters.

The connector assembly 218 can have any suitable design for purposes ofhaving the upper appliance member 214 and the lower appliance member 216be selectively and movably connected to one another. For example, asshown in FIG. 2A, the connector assembly 218 can include a firstconnector button 230A that is removably secured to the upper appliancemember 214, a second connector button 230B that is removably secured tothe lower appliance member 216, and a connector band 232 that isselectively secured or coupled to each of the upper appliance member 214and the lower appliance member 216, e.g., via the first connector button230A and the second connector button 230B, respectively. Alternatively,the connector assembly 218 can have another suitable design. Theconnector assembly 218 will be described in greater detail herein belowin relation to FIGS. 3A and 3B.

The teeth spacing assembly 220 is configured to enable the adjustmentand maintaining of a desired teeth spacing 21 (illustrated in FIG. 1)between the upper teeth 11A and the lower teeth 11B. Stated in anothermanner, the teeth spacing assembly 220 is configured such that the upperappliance member 214 and the lower appliance member 216, and thus theupper teeth 11A and the lower teeth 11B, cannot be positioned directlyadjacent to one another within the mouth 10 (illustrated in FIG. 1) ofthe patient.

The design of the teeth spacing assembly 220 can be varied. In variousembodiments, the teeth spacing assembly 220 includes a plurality ofvertical shims 234 that can be alternatively, removably secured to oneof the upper appliance member 214 and the lower appliance member 216,e.g., with features that can be encompassed and/or integrally formedwithin the vertical shim 234 and the appliance member 214, 216 to whichthe vertical shim 234 is being secured or coupled. As shown in FIG. 2A,when the vertical shim 234 is secured or coupled to one of the appliancemembers 214, 216, the vertical shim 234 is positioned substantiallydirectly between the upper appliance member 214 and the lower appliancemember 216 so as to define the teeth spacing 21 between the upper teeth11A and the lower teeth 11B.

It is appreciated that each of the plurality of vertical shims 234 canhave a different shim height such that the teeth spacing 21 between theupper teeth 11A and the lower teeth 11B can be adjusted as desired. Moreparticularly, in certain embodiments, the teeth spacing assembly 220 caninclude at least a first vertical shim 234A having a first shim height236A, and a second vertical shim 234B having a second shim height 236Bthat is different than the first shim height 236B. In such embodiments,(i) the first vertical shim 234A can be utilized such that the upperteeth 11A are spaced apart from the lower teeth 11B by a teeth spacing21 of at least the first shim height 236A when the first vertical shim234A is secured or coupled to one of the appliance members 214, 216; and(ii) the second vertical shim 234B can be utilized such that the upperteeth 11A are spaced apart from the lower teeth 11B by a teeth spacing21 of at least the second shim height 236B when the second vertical shim234B is secured or coupled to one of the appliance members 214, 216. Itis further appreciated that each of the vertical shims 234 can be usedalternatively to each of the other vertical shims 234, and/or multiplevertical shims 234 can be used in conjunction with one another toprovide even further options for the teeth spacing 21 between the upperteeth 11A and the lower teeth 11B. For example, in one non-exclusivealternative application, the first vertical shim 234A can be selectivelysecured or coupled to the upper appliance member 214 and the secondvertical shim 234B can be selectively secured or coupled to the lowerappliance member 216 such that the upper teeth 11A are spaced apart fromthe lower teeth 11B by a teeth spacing 21 of at least the first shimheight 236A plus the second shim height 236B.

In certain non-exclusive embodiments, the teeth spacing 21 that iscreated by using any individual vertical shim 234 and/or any combinationof vertical shims 234 can vary between approximately one millimeter andfive millimeters. Alternatively, in other embodiments, the verticalshims 234 can be sized and used individually or in combination withother vertical shims 234 to create teeth spacing 21 that is less thanapproximately one millimeter or greater than approximately fivemillimeters.

Additionally, during use of the oral appliance device 212 within themouth 10 of the patient including the use of the teeth spacing assembly220, the upper appliance member 214 and the lower appliance member 216are movable relative to one another between an open configuration and aclosed configuration. As utilized herein, the “closed configuration” isdefined as when at least one of the vertical shims 234 is positionedbetween the appliance members 214, 216, and there is no air spacebetween the vertical shims 234 and either of the appliance member 214,216, and/or between vertical shims 234 that are used in combination withother vertical shims 234 in a stacked relationship. Stated in anothermanner, when in the closed configuration, the upper appliance member 214(and thus the upper teeth 11A) and the lower appliance member 216 (andthus the lower teeth 11B) are as close as possible to one another exceptfor the presence of the vertical shim(s) 234 that are positioned betweenthe appliance members 214, 216. Conversely, the “open configuration” isdefined as when at least one of the vertical shims 234 is positionedbetween the appliance members 214, 216, and there is air space betweenthe vertical shims 234 and one of the appliance members 214, 216 (i.e.the appliance member 214, 216 which the vertical shim 234 is notremovably secured to), and/or between vertical shims 234 that are usedin combination with other vertical shims 234 in a stacked relationship.

In various embodiments, each of the vertical shims 234 can be formedfrom any suitable materials and/or can be formed from any suitablemanufacturing process. For example, in some non-exclusive embodiments,each of the vertical shims 234 can be formed from a nylon-basedmaterial, e.g., PA 2200 nylon, polyamide 12 nylon, or another suitablenylon material. Alternatively, each of the vertical shims 234 can beformed from other suitable materials.

Additionally, in certain non-exclusive alternative embodiments, each ofthe vertical shims 234 can be manufactured using one of athree-dimensional printer and a selective laser sintering process. Withsuch design, each of the vertical shims 234 can be quickly and easilymade or remade from a single model without the need for additionalimpressions or models. Alternatively, each of the vertical shims 234 canbe manufactured using another suitable process.

FIG. 2B is a partially exploded view illustration of a portion of theoral appliance device 212 illustrated in FIG. 2A. More particularly,FIG. 2B is an illustration of the upper appliance member 214 and atleast a portion of the teeth spacing assembly 220. As shown in FIG. 2B,the teeth spacing assembly 220 includes a pair of vertical shims 234,with one vertical shim 234 being configured to be removably secured toeach side of the upper appliance member 214.

The vertical shims 234 and/or the upper appliance member 214 can includeany suitable design features in order to selectively and/or removablycouple the vertical shims 234 to the upper appliance member 214. Incertain embodiments, as shown, the vertical shim 234 can include anappliance engager 238A that is integrally formed as part of the verticalshim 234, and the upper appliance member 214 can include a shim receiver238B that is integrally formed as part of the upper appliance member214. In such embodiments, the appliance engager 238A is configured toselectively engage the shim receiver 238B so that the vertical shim 234can be removably secured to the upper appliance member 214. In one suchembodiment, the appliance engager 238A can be provided in the form of acoarsely threaded post or screw that extends away from a shim surface234S, which is configured to rotatably engage the shim receiver 238B,e.g., a coarsely threaded aperture, that is formed into the upper membersurface 214A of the upper appliance member 214. With such design, theappliance engager 238A can be rotatably and/or threadingly receivedwithin the shim receiver 238B. Additionally, in such embodiment, thevertical shim 234 is movable between a disengaged configuration, whereinwhen in the disengaged configuration the vertical shim 234 can beselectively secured or coupled to and removed from the upper appliancemember 214, and an engaged configuration, wherein when in the engagedconfiguration the vertical shim 234 cannot be removed from the upperappliance member 214.

Further, in some embodiments, the vertical shim 234 and/or the upperappliance member 214 can also include an alignment system 238C, e.g., asmall bump and recess combination, to more effectively align thecoupling between the vertical shim 234 and the upper appliance member214 when the vertical shim 234 is in the engaged configuration. Moreparticularly, in such embodiments, when properly aligned with thevertical shim 234 in the engaged configuration, the small bump on one ofthe vertical shim 234 and the upper appliance member 214 will fit and beretained within the small recess on the other of the vertical shim 234and the upper appliance member 214. Alternatively, the vertical shim 234and/or the upper appliance member 214 can be designed without thealignment system 238C.

It is appreciated that a similar design can be incorporated into aremovable coupling between the vertical shims 234 and the lowerappliance member 216 (illustrated in FIG. 2A).

Additionally, or in the alternative, the appliance engager 238A of thevertical shim 234 and/or the shim receiver 238B of the upper appliancemember 214 can have another suitable design. For example, in onenon-exclusive alternative embodiment, the appliance engager 238A can beprovided in the form of at least one post that extends away from a shimsurface 234S of the vertical shim 234, and the shim receiver 238B can beprovided in the form of at least one aperture that is formed into thesurface 214A of the upper appliance member 214. With such design, eachof the at least one aperture of the shim receiver 238B is sized andshaped to receive one of the at least one post of the appliance engager238A, such that the vertical shim 234 can be removably secured to theupper appliance member 214.

As shown, when the vertical shim 234 is removably secured to the upperappliance member 214, the shim surface 234S of the vertical shim 234 ispositioned substantially directly adjacent to the upper member surface214A of the upper appliance member 214.

FIG. 2C is a partially exploded view illustration of another portion ofthe oral appliance device 212 illustrated in FIG. 2A. More particularly,FIG. 2C is an illustration of the lower appliance member 216 and atleast a portion of the teeth spacing assembly 220. As shown in FIG. 2C,the teeth spacing assembly 220 includes a pair of vertical shims 234,with one vertical shim 234 being configured to be removably secured toeach side of the lower appliance member 216.

The vertical shim 234 and/or the lower appliance member 216 can includeany suitable design features in order to selectively and/or removablycouple the vertical shims 234 to the lower appliance member 216. Incertain embodiments, as shown, the vertical shim 234 can include anappliance engager 238A that is integrally formed as part of the verticalshim 234, and the lower appliance member 216 can include a shim receiver238B that is integrally formed as part of the lower appliance member216. In such embodiments, the appliance engager 238A is configured toselectively engage the shim receiver 238B so that the vertical shim 234can be removably secured to the lower appliance member 216. In one suchembodiment, the appliance engager 238A can be provided in the form of atleast one post (two are shown on each vertical shim 234 in FIG. 2C) thatextends away from a shim surface 234S of the vertical shim 234, andwhich are configured to engage the shim receiver 238B, e.g., at leastone aperture (two are shown on each side of the lower appliance member216), that is formed into the lower member surface 216A of the lowerappliance member 216. With such design, each of the at least oneaperture of the shim receiver 238B is sized and shaped to receive one ofthe at least one post of the appliance engager 238A, such that thevertical shim 234 can be selectively and removably secured to the lowerappliance member 216.

It is appreciated that a similar design can be incorporated into aremovable coupling between the vertical shims 234 and the upperappliance member 214 (illustrated in FIG. 2A).

Additionally, or in the alternative, the appliance engager 238A of thevertical shim 234 and/or the shim receiver 238B of the lower appliancemember 216 can have another suitable design. For example, in onenon-exclusive alternative embodiment, the appliance engager 238A can beprovided in the form of a coarsely threaded post or screw that extendsaway from the shim surface 234A, which is configured to rotatably engagethe shim receiver 238B, e.g., a coarsely threaded aperture, that isformed into the lower member surface 216A of the lower appliance member216. With such alternative design, the vertical shim 234 can be movablebetween a disengaged configuration, wherein when in the disengagedconfiguration the vertical shim 234 can be selectively secured orcoupled to and removed from the lower appliance member 216, and anengaged configuration, wherein when in the engaged configuration thevertical shim 234 cannot be removed from the lower appliance member 216.

As shown, when the vertical shim 234 is removably secured to the lowerappliance member 216, the shim surface 234S of the vertical shim 234will be positioned substantially directly adjacent to the lower membersurface 216A of the lower appliance member 216.

As noted above, the teeth spacing assembly 220 can alternatively use anyof a plurality of vertical shims 234 of different shim heights 236A,236B (illustrated in FIG. 2A) by removably coupling the vertical shim(s)234 to one of the appliance members 214, 216. Additionally, as shown inFIG. 2C, each of the vertical shims 234 can be said to have a shimlength 234L and a shim width 234W, in addition to the shim height 236A,236B. It is appreciated that in addition to the alternative use ofvertical shims 234 having different shim heights 236A, 236B, the teethspacing assembly 220 can also include alternative vertical shims 234having different shim lengths 234L and/or different shim widths 234W.The use of any such alternative vertical shims 234 as part of the teethspacing assembly 220, i.e. having different shim lengths 234L, shimwidths 234W and/or shim heights 236A, 236B, is to provide the healthcareprofessional and/or the patient with suitable options to better fit theparticular size and shape of the mouth 10 (illustrated in FIG. 1) of thepatient, as well as being better able to provide the desired treatmentfor the patient.

FIG. 3A is a simplified side view illustration of another embodiment ofthe oral appliance device 312. More specifically, in the embodimentshown in FIG. 3A, the oral appliance device 312 includes an upperappliance member 314, a lower appliance member 316, and a connectorassembly 318 that selectively and movably connects the upper appliancemember 314 and the lower appliance member 316 to one another. In certainnon-exclusive alternative embodiments, the oral appliance device 312 canfurther include one or more of the teeth spacing assembly 220(illustrated in FIG. 2A), the nasal dilator assembly 422 (illustrated inFIG. 4A), the tongue positioner assembly 524 (illustrated in FIG. 5A)and the jaw position controller 626 (illustrated in FIG. 6A).

As with the previous embodiments, as well as all other embodimentsillustrated and described herein, during use of the oral appliancedevice 312, the upper appliance member 314 is positioned to selectivelyengage the upper teeth 11A (illustrated in FIG. 1) and the lowerappliance member 316 is positioned to selectively engage the lower teeth11B (illustrated in FIG. 1).

The connector assembly 318 can have any suitable design. As illustratedin this embodiment, the connector assembly 318 includes (i) a firstconnector button 330A that is removably secured to the upper appliancemember 314, i.e. toward a front 314F of the upper appliance member 314;(ii) a second connector button 330B that is removably secured to thelower appliance member 316, i.e. toward a rear 316R of the lowerappliance member 316; and (iii) a connector band 332 that is selectivelysecured or coupled to each of the upper appliance member 314 (i.e. viathe first connector button 330A) and the lower appliance member 316(i.e. via the second connector button 330B). It is appreciated that withthe connector band 332 being secured or coupled to the upper appliancemember 314 toward the front 314F of the upper appliance member 314 andbeing secured or coupled to the lower appliance member 316 toward therear 316R of the lower appliance member 316, the connector band 332 isable to inhibit the lower teeth 11B (and the lower jaw 17B (illustratedin FIG. 1)) from falling back in a supine position and potentiallyblocking the upper airway of the individual.

In various embodiments, the first connector button 330A and the secondconnector button 330B can be formed from any suitable materials and/orcan be formed from any suitable manufacturing process. For example, insome non-exclusive embodiments, each of the connector buttons 330A, 330Bcan be formed from a nylon-based material, e.g., PA 2200 nylon,polyamide 12 nylon, or another suitable nylon material. Alternatively,each of the connector buttons 330A, 330B can be formed from othersuitable materials.

Additionally, in certain non-exclusive alternative embodiments, each ofthe connector buttons 330A, 330B can be manufactured using one of athree-dimensional printer and a selective laser sintering process. Withsuch design, each of the connector buttons 330A, 330B can be quickly andeasily made or remade from a single model without the need foradditional impressions or models. Alternatively, each of the connectorbuttons 330A, 330B can be manufactured using another suitable process.

As noted, the connector band 332 is selectively secured or coupled toeach of the upper appliance member 314 (i.e. via the first connectorbutton 330A) and the lower appliance member 316 (i.e. via the secondconnector button 330B). The connector band 332 can have any suitabledesign for purposes of selectively and movably coupling the upperappliance member 314 and the lower appliance member 316. In someembodiments, the connector band 332 can be elastic to allow forminimized relative movement or retrusion between the jaws. In otherembodiments, the connector band 332 can be more rigid. In the embodimentillustrated in FIG. 3A, the connector band 332 includes a first band end332A that is selectively secured or coupled to the upper appliancemember 314, a second band end 332B that is selectively secured orcoupled to the lower appliance member 316, and an elongated, band body332C that extends between the first band end 332A and the second bandend 332B.

As shown, each of the first band end 332A and the second band end 332Bcan be substantially rectangle-shaped or square-shaped. As such, each ofthe first band end 332A and the second band end 332B include at leasttwo substantially linear edges that are at an angle, e.g., substantiallyperpendicular, relative to one another. Additionally, as illustrated,the connector band 332 is uniquely configured such that the first bandend 332A does not extend above an upper extreme, or upper edge 314X, ofthe upper appliance member 314, and the second band end 332B does notextend below a lower extreme, or lower edge 316X, of the lower appliancemember 316. With such design, the connector band 332, i.e. the band ends332A, 332B, is generally configured so as to not aggravate the lip orgum area adjacent to where the band ends 332A, 332B are secured orcoupled to the upper appliance member 314 and the lower appliance member316, respectively. Alternatively, the first band end 332A and/or thesecond band end 332B can have a different shape, e.g., a round shape, anoval shape, a triangle shape, a diamond shape, or another suitableshape.

The connector band 332 can be formed from any suitable materials and/orcan be formed from any suitable manufacturing process. Moreparticularly, in various embodiments, the connector band 332 can becomposed of materials having different shoreness and flexibilityprofiles, each having different characteristics, features, and benefits.Additionally, different wear rates can be provided for with differentmaterials and compositions for the connector band 332. As such, theconnector band 332 can enable the healthcare professional to monitor useof the connector band 332 as a feedback device. For example, if patientsare wearing through the connector band 332 rapidly or frequentlybreaking the connector band 332, this can indicate that additional orother components may require adjustment or analysis, for example, anasal dilator component.

In some non-exclusive embodiments, the connector band 332 can be formedfrom a nylon-based material, e.g., PA 2200 nylon, polyamide 12 nylon, oranother suitable nylon material. Alternatively, in another embodiment,the connector band 332 can be formed from an elastomeric material, suchas medium-grade santoprene. Still alternatively, the connector band 332can be formed from one or more materials or compositions such assilicone, elastosil, rubber, and others that provide some amount offlexibility. Yet alternatively, the connector band 332 can be formedfrom other suitable materials.

Additionally, in certain non-exclusive alternative embodiments, theconnector band 332 can be manufactured using one of a three-dimensionalprinter and a selective laser sintering process. Alternatively, theconnector band 332 can be manufactured using another suitable process.

FIG. 3B is a partially exploded view illustration of the oral appliancedevice 312 illustrated in FIG. 3A. In particular, FIG. 3B illustratesdetails of the connector assembly 318 that shows how the connectorassembly 318 and/or the connector band 332 can be selectively andremovably secured to the upper appliance member 314 and the lowerappliance member 316.

As shown in FIG. 3B, in addition to the connector buttons 330A, 330B andthe connector band 332, the connector assembly 318 further includes afirst connector base 340A that is secured to and/or integrally formedwith the upper appliance member 314, and a second connector base 340Bthat is secured to and/or integrally formed with the lower appliancemember 316. In some embodiments, the first connector base 340A caninclude a first base aperture 342A that is internally threaded; and thesecond connector base 340B can include a second base aperture 342B thatis also internally threaded.

Additionally, in this embodiment, the first connector button 330Aincludes a first button head 344A and a first button shaft 346A thatextends away from the first button head 344A. As illustrated, the firstbutton shaft 346A can include external threads that are configured tothreadingly engage the internal threads of the first base aperture 342Aof the first connector base 340A. Similarly, the second connector button330B includes a second button head 344B and a second button shaft 346Bthat extends away from the second button head 344B. As illustrated, thesecond button shaft 346B can include external threads that areconfigured to threadingly engage the internal threads of the second baseaperture 342B of the second connector base 340B.

Further, as shown, the first band end 332A of the connector band 332includes a first band aperture 348A, and the second band end 332B of theconnector band 332 includes a second band aperture 348B.

With the design of the connector assembly 318 as described in detailherein, the connector band 332 and/or the connector buttons 330A, 330Bcan be removably secured to the upper appliance member 314 and the lowerappliance member 316. More specifically, when it is desired to couplethe connector band 332 to the upper appliance member 314, the externallythreaded first connector shaft 346A of the first connector button 330Ais extended through the first band aperture 348A of the first band end332A of the connector band 332 and is threaded into the first baseaperture 342A of the first connector base 340A. Thus, the firstconnector button 330A is threadingly secured or coupled to the upperappliance member 314, and the connector band 332 is thus selectivelysecured or coupled to the upper appliance member 314 via the firstconnector button 330A that is removably secured to the upper appliancemember 314. Similarly, when it is desired to couple the connector band332 to the lower appliance member 316, the externally threaded secondconnector shaft 346B of the second connector button 330B is extendedthrough the second band aperture 348B of the second band end 332B of theconnector band 332 and is threaded into the second base aperture 342B ofthe second connector base 340B. Thus, the second connector button 330Bis threadingly secured or coupled to the lower appliance member 316, andthe connector band 332 is thus selectively secured or coupled to thelower appliance member 316 via the second connector button 330B that isremovably secured to the lower appliance member 316.

FIG. 4A is a simplified perspective view illustration of still anotherembodiment of the oral appliance device 412. In particular, FIG. 4Aillustrates the oral appliance device 412 including the upper appliancemember 414, and an embodiment of the nasal dilator assembly 422 that issecured or coupled to the upper appliance member 414. The lowerappliance member is not illustrated in FIG. 4A for purposes of clarity,as the nasal dilator assembly 422, as noted, is specifically secured orcoupled to the upper appliance member 414. However, it is appreciatedthat this embodiment of the oral appliance device 412 will alsotypically include the lower appliance member. Additionally, in certainnon- exclusive alternative embodiments, the oral appliance device 412can further include one or more of the teeth spacing assembly 220(illustrated in FIG. 2A), the connector assembly 318 (illustrated inFIG. 3A), the tongue positioner assembly 524 (illustrated in FIG. 5A),the jaw position controller 626 (illustrated in FIG. 6A), and the Herbstdevice assembly 728 (illustrated in FIG. 7A).

As with the other embodiments, during use of the oral appliance device412, the upper appliance member 414 is sized, shaped and positioned toselectively engage the upper teeth 11A (illustrated in FIG. 1). Asshown, the upper appliance member 414 can include a molding or castingof the patient's upper teeth 11A and a portion of surrounding oralgeography. The molding or casting of the upper teeth 11A can be taken inany suitable manner. For example, one type of molding can include takingimages of a patient's oral anatomy with a digital scanner or fromimpressions using a computer to map them before fabricating a molding.Additionally, in certain non-exclusive alternative embodiments, theupper appliance member 414 can then be manufactured using one of athree-dimensional printer and a selective laser sintering process.Intraoral scanners can allow patient information to be captured andstored in digital format before being transmitted or otherwise deliveredto the three-dimensional printer or the selective laser sintering devicefor fabrication. Further, it is appreciated that in embodiments thatalso include the lower appliance member, the lower appliance member canbe formed in a similar manner. Still further, it is also appreciatedthat in certain embodiments, the upper appliance member 414 (and thelower appliance member) can be formed from any suitable nylon-basedmaterials.

The nasal dilator assembly 422 is configured to dilate the nasal passageof the patient, thereby improving airflow through the nasal-pharyngealpassageways. Additionally, in this embodiment, the nasal dilatorassembly 422 is configured to dilate the nasal passage of the patientwhile being positioned entirely within the oral cavity of the patient.The design of the nasal dilator assembly 422 can be varied to suit therequirements of the oral appliance device 412 and/or the specific needsof the patient. In certain embodiments, as shown in FIG. 4A, the nasaldilator assembly includes a first dilator receiver 450A, a seconddilator receiver 450B, a first nasal dilator 452A that is removably andadjustably secured or coupled to the first dilator receiver 450A, and asecond nasal dilator 452B that is removably and adjustably secured orcoupled to the second dilator receiver 450B. Alternatively, the nasaldilator assembly 422 can include more components or fewer componentsthan those specifically illustrated and described herein. For example,in one non-exclusive alternative embodiment, the nasal dilator assembly422 need only include one dilator receiver 450A, 450B and one nasaldilator 452A, 452B that is removably and adjustably secured or coupledto the one dilator receiver 450A, 450B.

In one embodiment, each of the first dilator receiver 450A and thesecond dilator receiver 450B are integrally formed with the upperappliance member 414 during manufacturing of the upper appliance member414. Alternatively, in another embodiment, the first dilator receiver450A and/or the second dilator receiver 450B can be manufacturedindependently, and can then be permanently or removably affixed,attached, secured, connected or otherwise secured or coupled to theupper appliance member 414 during a post-manufacturing process.

Additionally, the first dilator receiver 450A is configured to hold ormaintain the first nasal dilator 452A in a fixed or minimally movableposition when the first nasal dilator 452A is selectively (andremovably) secured or coupled to the first dilator receiver 450A.Similarly, the second dilator receiver 450B is configured to hold ormaintain the second nasal dilator 452B in a fixed or minimally movableposition when the second nasal dilator 452B is selectively (andremovably) secured or coupled to the second dilator receiver 450B.

Referring briefly to FIG. 4B, FIG. 4B is a simplified top viewillustration of a portion of the oral appliance device 412 illustratedin FIG. 4A. More specifically, FIG. 4B illustrates the upper appliancemember 414, and further illustrates details of the first dilatorreceiver 450A and the second dilator receiver 450B, which are secured toand/or integrally formed with the upper appliance member 414.

As shown in FIG. 4B, the first dilator receiver 450A includes a firstreceiver channel 454A that is configured to selectively and removablyreceive and retain a portion of the first nasal dilator 452A(illustrated in FIG. 4A). The first receiver channel 454A can have agenerally constant rectangular, square, v-shaped, semicircular or othercross-sectional profile with one or more walls creating sides of thefirst receiver channel 454A. Additionally, the first receiver channel454A can be open at one or more locations. For example, as shown in FIG.4B, the first receiver channel 454A is open at an upper location of thefirst dilator receiver 450A, with the opening being located between theupper lip and gums of the patient. Further, the first receiver channel454A can be configured to extend substantially vertically or at variousangles as it extends downward within the first dilator receiver 450A.While the walls of the first receiver channel 454A can generally retainthe portion of the first nasal dilator with frictional resistance, insome embodiments, the first receiver channel 454A can include securingcomponents, e.g., ledges, ridges, latches, flaps, etc., in variouslocations so that the portion of the first nasal dilator 452A can bemore effectively retained therein.

Similarly, the second dilator receiver 450B includes a second receiverchannel 454B that is configured to selectively and removably receive andretain a portion of the second nasal dilator 452B (illustrated in FIG.4A). The second receiver channel 454B can have a generally constantrectangular, square, v-shaped, semicircular or other cross-sectionalprofile with one or more walls creating sides of the second receiverchannel 454B. Additionally, the second receiver channel 454B can be openat one or more locations. For example, as shown in FIG. 4B, the secondreceiver channel 454B is open at an upper location of the second dilatorreceiver 450B, with the opening being located between the upper lip andgums of the patient. Further, the second receiver channel 454B can beconfigured to extend substantially vertically or at various angles as itextends downward within the second dilator receiver 450B. While thewalls of the second receiver channel 454B can generally retain theportion of the first nasal dilator with frictional resistance, in someembodiments, the second receiver channel 454B can include securingcomponents, e.g., ledges, ridges, latches, flaps, etc., in variouslocations so that the portion of the second nasal dilator 452B can bemore effectively retained therein.

Additionally, in some embodiments, the first dilator receiver 450Aand/or the first receiver channel 454A can be located on a frontalsurface of the upper appliance member 414, exterior to a tooth bed, andalong and/or near a first side 414F of the upper appliance member 414.The first dilator receiver 450A and/or the first receiver channel 454Acan further have a slope of between approximately forty-five degrees andsixty degrees from a plane across the upper teeth 11A (illustrated inFIG. 1), and may be positioned so that it slopes downward toward acentral location of the upper appliance member 414 between the centralincisors and angles upward toward the buccal sulcus 13 (illustrated inFIG. 1). More particularly, in one such embodiment, the first dilatorreceiver 450A and/or the first receiver channel 454A can begin in frontof a canine or incisor and end in front of a lateral incisor facing thebuccal sulcus 13.

Similarly, in some embodiments, the second dilator receiver 450B and/orthe second receiver channel 454B can be located on a frontal surface ofthe upper appliance member 414, exterior to a tooth bed, and alongand/or near a second side 414S of the upper appliance member 414. Thesecond dilator receiver 450B and/or the second receiver channel 454B canfurther have a slope of between approximately forty-five degrees andsixty degrees from a plane across the upper teeth 11A, and may bepositioned so that it slopes downward toward a central location of theupper appliance member 414 between the central incisors and anglesupward toward the buccal sulcus 13. More particularly, in one suchembodiment, the second dilator receiver 450B and/or the second receiverchannel 454B can begin in front of a canine or incisor and end in frontof a lateral incisor facing the buccal sulcus 13.

In various embodiments, the first dilator receiver 450A and the seconddilator receiver 450B can be formed from any suitable materials and/orcan be formed from any suitable manufacturing process. For example, insome non-exclusive embodiments, each of the dilator receivers 450A, 450Bcan be formed from a nylon-based material, e.g., PA 2200 nylon,polyamide 12 nylon, or another suitable nylon material. Alternatively,each of the dilator receivers 450A, 450B can be formed from othersuitable materials.

Additionally, in certain non-exclusive alternative embodiments, each ofthe dilator receivers 450A, 450B can be manufactured using one of athree-dimensional printer and a selective laser sintering process. Withsuch design, each of the dilator receivers 450A, 450B can be quickly andeasily made or remade from a single model without the need foradditional impressions or models. Alternatively, each of the dilatorreceivers 450A, 450B can be manufactured using another suitable process.

Referring back to FIG. 4A, as shown, the first nasal dilator 452A isremovably secured or coupled to the first dilator receiver 450A and thusthe upper appliance member 414, i.e. with a portion of the first nasaldilator 452A removably retained within the first receiver channel 454A(illustrated in FIG. 4B); and the second nasal dilator 452B is removablysecured or coupled to the second dilator receiver 450B and thus theupper appliance member 414, i.e. with a portion of the second nasaldilator 452B removably retained within the second receiver channel 454B(illustrated in FIG. 4B). With the nasal dilators 452A, 452B so securedor coupled to the dilator receivers 450A, 450B, the nasal dilators 452A,452B can be selectively and adjustably positioned to push the upper lipof the patient into a position that is located away and spaced apartfrom the maxillary dental arch of the patient. When properly positioned,the nasal dilators 452A, 452B can effectively dilate the nasal passageof the patient, thereby improving airflow through the nasal-pharyngealairways.

It is appreciated that each of the first nasal dilator 452A and thesecond nasal dilator 452B can be substantially similar in design andfunction. However, with the modular design of the nasal dilators 452A,452B, as described in detail herein, it is further appreciated that thespecific dimensions and positioning of any components of the nasaldilators 452A, 452B can be varied to suit the particular anatomicalrequirements of the patient with whom the nasal dilator assembly 422 isbeing used. In various embodiments, each of the nasal dilators 452A,452B can include a dilator positioner 456, e.g., a wire, and a dilatorbulb 458 that is removably or permanently secured or coupled to thedilator positioner 456.

Referring now to FIG. 4C, FIG. 4C is a partially exploded viewillustration of a portion of the oral appliance device 412 illustratedin FIG. 4A. In particular, FIG. 4C illustrates the nasal dilatorassembly 422 with the nasal dilators 452A, 452B being spaced apart fromthe dilator receivers 450A, 450B, respectively.

In various embodiments, the dilator positioner 456 is flexible and/orbendable such that the dilator positioner 456 can be maneuvered andmanipulated as desired to enable better and/or more precise positioningof the dilator bulb 458. Additionally, the dilator positioner 456 isconfigured to extend into and be removably retained within the receiverchannel 454A, 454B (illustrated in FIG. 4B) of the dilator receiver450A, 450B. In some embodiments, the walls of the receiver channel 454A,454B can provide frictional resistance to the dilator positioner 456that is positioned within the receiver channel 454A, 454B to inhibit thenasal dilator 452A, 452B from becoming dislodged from the body of theupper appliance member 414. Further, with the flexibility of the dilatorpositioner 456, frictional resistance within the receiver channel 454A,454B to movement of the dilator positioner 456 can be increased ordecreased by modifying, manipulating, or moving one or more bends orloops of the dilator positioner 456 closer together or farther apart.With the dilator positioner 456 effectively retained within the receiverchannel 454A, 454B, the dilator bulb 458 can then be maintained in afixed or semi-fixed position, as desired, with respect to the upperappliance member 414. Additionally, it is appreciated that with themaneuverability and flexibility of the dilator positioner 456, the nasaldilator 452A, 452B can be easily removed from the receiver channel 454A,454B if necessary to adjust the nasal dilator 452A, 452B for improvedfunctionality or replacement.

The dilator positioner 456 can be of any suitable size and can formedfrom any suitable materials. For example, in certain embodiments, thedilator positioner 456 can be formed from stainless steel and can have acircular cross-section that is between approximately 0.03 millimetersand 0.04 millimeters in diameter. Alternatively, the dilator positioner456 can have a different size and shape, and/or the dilator positioner456 can be formed from any other suitable materials.

As noted above, in alternative embodiments, the dilator bulb 458 can beremovably or permanently secured or coupled to the dilator positioner456. Additionally, with the flexibility of the dilator positioner 456,the dilator bulb 458 can be better positioned as desired. Moreparticularly, the dilator bulb 458 can be rotated and repositioned,anteriorly, posteriorly, laterally, or in other directions, bymanipulating and changing the angle of the dilator positioner 456. Assuch, the dilator positioner 456 can maintain the dilator bulb 458 in afixed or semi-fixed position with respect to the upper appliance member414, thus inhibiting any undesired movement of the dilator bulb 458relative to the upper appliance member 414, even if the patient moves.Thus, the patient and/or the healthcare professional are able to freelymove, adjust, remove, and otherwise adjust or manipulate the dilatorbulb 458 as necessary.

The dilator bulb 458 can have any suitable design. For example, in somenon-exclusive embodiments, the dilator bulb 458 can be generally planarand/or can be somewhat cylindrical-shaped, conical-shaped,spherical-shaped, tear drop-shaped, or another suitable regular orirregular shape.

Additionally, the dilator bulb 458 can be designed to have any desiredshore hardness and rigidity, and can be of any suitable size. Forexample, in certain embodiments, the dilator bulb 458 can be modifiedbetween soft, medium and hard firmness, and the size can be modifiedbetween small, medium and large in varying degrees. As such, thehealthcare professional can select an appropriate nasal dilator 452A,452B and/or an appropriate dilator bulb 458 from a plurality ofalternative nasal dilators, where each nasal dilator has a certaindegree of freedom of movement for correct positioning according to theunique anatomy of each individual patient. Thus, the healthcareprofessional is better able to attend to and address the needs of eachpatient individually. Additionally, different nasal dilator sizes can beconsidered when selecting an appropriate nasal dilator, and a nasaldilator can be easily exchanged if improper or undesired results arelikely to occur, thus optimizing treatments on a per patient basis.

Further, with the noted flexibility of the dilator positioner 456, bymodifying, manipulating or moving bends or loops of the dilatorpositioner 456, the dilator bulb 458 can be positioned to allow thedilator bulb 458 to provide increased or decreased resistance to lip,nasal or other nearby structures when adjusted. Thus, the dilator bulb458 can be positioned in any suitable manner, as desired, within theoral cavity of the patient, to provide the desired treatment options forthe patient.

The dilator bulb 458 can be formed from any suitable materials. Forexample, in one embodiment, the dilator bulb 458 can be formed from anylon-based material, e.g., PA 2200 nylon, polyamide 12 nylon, oranother suitable nylon material. Alternatively, in another embodiment,e.g., when soft firmness is desired, the dilator bulb 458 can be formedfrom an organic compound such as ethyl-methacrylate. Stillalternatively, in still another embodiment, e.g., when hard firmness isdesired, the dilator bulb 458 can be formed from an organic compoundsuch as methyl-methacrylate. Yet alternatively, the dilator bulb 458 canbe formed from other suitable materials.

Additionally, in certain non-exclusive alternative embodiments, thedilator bulb 458 can be manufactured using one of a three-dimensionalprinter and a selective laser sintering process. Alternatively, thedilator bulb 458 can be manufactured using another suitable process.

FIG. 5A is a simplified top perspective view illustration of anotherembodiment of the oral appliance device 512. In particular, FIG. 5Aillustrates the oral appliance device 512 including the lower appliancemember 516, and an embodiment of the tongue positioner assembly 524 thatis secured or coupled to the lower appliance member 516. The upperappliance member is not illustrated in FIG. 5A for purposes of clarity,as the tongue positioner assembly 524, as noted, is specifically securedor coupled to the lower appliance member 516. However, it is appreciatedthat this embodiment of the oral appliance device 512 will alsotypically include the upper appliance member. Additionally, in certainnon-exclusive alternative embodiments, the oral appliance device 512 canfurther include one or more of the teeth spacing assembly 220(illustrated in FIG. 2A), the connector assembly 318 (illustrated inFIG. 3A), the nasal dilator assembly 422 (illustrated in FIG. 4A), thejaw position controller 626 (illustrated in FIG. 6A), and the Herbstdevice assembly 728 (illustrated in FIG. 7A).

As with the other embodiments, during use of the oral appliance device512, the lower appliance member 516 is sized, shaped and positioned toselectively engage the lower teeth 11B (illustrated in FIG. 1). Asshown, the lower appliance member 516 can include a molding or castingof the patient's lower teeth 11B and a portion of surrounding oralgeography. The molding or casting of the lower teeth 11B can be taken inany suitable manner. For example, one type of molding can include takingimages of a patient's oral anatomy with a digital scanner or fromimpressions using a computer to map them before fabricating a molding.Additionally, in certain non-exclusive alternative embodiments, thelower appliance member 516 can then be manufactured using one of athree-dimensional printer and a selective laser sintering process.Intraoral scanners can allow patient information to be captured andstored in digital format before being transmitted or otherwise deliveredto the three-dimensional printer or the selective laser sintering devicefor fabrication. Further, it is appreciated that in embodiments thatalso include the upper appliance member, the upper appliance member canbe formed in a similar manner. Still further, it is also appreciatedthat in certain embodiments, the lower appliance member 516 (and theupper appliance member) can be formed from any suitable nylon-basedmaterials.

The tongue positioner assembly 524 is configured to adjust the positionof the tongue 15 (illustrated in FIG. 1) within the mouth 10(illustrated in FIG. 1) of the patient. More specifically, in variousembodiments, the tongue positioner assembly 524 is configured to pullthe base of the tongue 15 of the patient forward, thus repositioning thelower jaw 17B (illustrated in FIG. 1) and tongue 15 of the patient in ananterior position. Thus, the tongue positioner assembly 524 can increasethe area available for air passage in the posterior pharyngeal region,thereby opening the breathing passage behind the tongue 15 and improvingpatient respiration.

Additionally, as provided herein, the tongue positioner assembly 524 canhave a modular design that incorporates one or more tongue positioners560 (illustrated in FIG. 5B), which can be selectively, alternativelyand removably attached to the lower appliance member 516 within themouth 10 of the patient. For example, in many embodiments, the tonguepositioner assembly 524 and/or the oral appliance device 512 includes atongue positioner 560 that is alternatively and removably attached to aninner surface 516S on either side of the lower appliance member 516.Additionally, each tongue positioner 560 can have any suitable size andshape, and can be positioned with any desired orientation within themouth 10 of the patient. Stated in another manner, the tongue positionerassembly 524 enables the healthcare professional and/or the patient toselect from a wide variety of alternative options for the specificdesign and positioning of the tongue positioner 560. Thus, with themultitude of available alternative options for the specific design andorientation of the tongue positioner 560, the healthcare professional isbetter able to alleviate snoring and other sleep-related problems forhis or her patients, as compared with current non-invasive treatmentmethods and invasive treatment methods including surgery.

The design of the tongue positioner assembly 524 can be varied to suitthe specific requirements of the oral appliance device 512 and/or thespecific anatomical requirements of the patient with whom the tonguepositioner assembly 524 is being used. In various embodiments, thetongue positioner assembly 524 includes one or more tongue positioners560, with the lower appliance member 516 including a positioner receiver564A and with each of the one or more tongue positioners including anappliance engager 564B (illustrated in FIG. 5B) for selectively andremovably attaching the tongue positioners 560 to the inner surface 516Son either side of the lower appliance member 516. Alternatively, thetongue positioner assembly 524 can include more components or fewercomponents than those illustrated and described herein, and/or thespecific design of the tongue positioners 560 and the lower appliancemember 516 can be different than what is illustrated and describedherein.

Referring now to FIG. 5B, FIG. 5B is a partially exploded viewillustration of the oral appliance device 512 illustrated in FIG. 5A.Additionally, FIG. 5B illustrates that the tongue positioners 560 thatare usable as part of the tongue positioner assembly 524 can have anysuitable size, shape and orientation when used and positioned as desiredwithin the mouth 10 (illustrated in FIG. 1) of the patient. Morespecifically, FIG. 5B illustrates a first tongue positioner 560A thathas already been removably attached to the lower appliance member 516,and a second tongue positioner 560B and a third tongue positioner 560Cthat can additionally and/or alternatively be removably attached to thelower appliance member 516. As provided herein, each of the tonguepositioners 560A, 560B, 560C can have a different size and/or shape.Alternatively, one or more of the tongue positioners 560A, 560B, 560Ccan be substantially similar in shape.

In certain embodiments, the tongue positioner 560 can have dimensionsincluding a length that is between approximately ten millimeters andthirteen millimeters, a width that is between approximately fivemillimeters and seven millimeters, and a thickness that is betweenapproximately four millimeters and six millimeters. Alternatively, inother embodiments, the tongue positioner 560 can have dimensionsincluding a length that is between approximately eighteen millimetersand twenty-one millimeters, a width that is between approximately fivemillimeters and seven millimeters, and a thickness that is betweenapproximately four millimeters and six millimeters. Still alternatively,in still other embodiments, the tongue positioner 560 can havedimensions where the length, the width and/or the thickness aredifferent than the specific examples listed herein above.

In various embodiments, each of the tongue positioners 560 can be formedfrom any suitable materials and/or can be formed from any suitablemanufacturing process. For example, in some non-exclusive embodiments,each of the tongue positioners 560 can be formed from a nylon-basedmaterial, e.g., PA 2200 nylon, polyamide 12 nylon, or another suitablenylon material. Alternatively, each of the tongue positioners 560 can beformed from other suitable materials.

Additionally, in certain non-exclusive alternative embodiments, each ofthe tongue positioners 560 can be manufactured using one of athree-dimensional printer and a selective laser sintering process. Withsuch design, each of the tongue positioners 560 can be quickly andeasily made or remade from a single model without the need foradditional impressions or models. Alternatively, each of the tonguepositioners 560 can be manufactured using another suitable process.

The tongue positioners 560 and/or the lower appliance member 516 caninclude any suitable design features for purposes of selectively andremovably attaching the tongue positioner 560 to the lower appliancemember 516. For example, as noted above and as shown more clearly inFIG. 5A, the lower appliance member 516 can include a pair of positionerreceivers 564A for purposes of selectively and removably attaching oneof the tongue positioners 560 to the inner surface 516S on either sideof the lower appliance member 516. Further, as noted, the use of thetongue positioners 560 allows for improved respiration for the patientby repositioning the lower jaw 17B and tongue 15 (illustrated in FIG. 1)in an interior position, thereby opening the breathing passage behindthe tongue 15 to better enable the healthcare professional to alleviatesnoring and other sleep-related problems for his or her patients.

In certain embodiments, each positioner receiver 564A can be integrallyformed with the lower appliance member 516. Alternatively, eachpositioner receiver 564A can be separately formed and independentlysecured to the lower appliance member. Additionally, each tonguepositioner 560 can include an appliance engager 564B that is integrallyformed as part of the tongue positioner 560. In such embodiments, theappliance engager 564B is configured to selectively engage thepositioner receiver 564A so that the tongue positioner 560 can beselectively and removably secured to the lower appliance member 516.

The positioner receiver 564A and the appliance engager 564B can have anysuitable design for purposes of selectively and removably attaching thetongue positioners 560 to the lower appliance member 516. For example,in some embodiments, as shown in FIGS. 5A and 5B, the positionerreceiver 564A can include and/or incorporate a generally “T-shaped”receiver extension 565 that is secured or coupled to and extends awayfrom the inner surface 516S of the lower appliance member 516. In suchembodiments, the T-shaped receiver extension 565 can be oriented suchthat the cross at the top is substantially parallel to the inner surface516S of the lower appliance member 516 from which the perpendicularbottom section of the T-shaped extension 565 extends. The top of thereceiver extension 565 can also be referred to herein as an “interiorridge”. The interior ridge is operable to support and maintain theposition of the tongue positioner 560 relative to the lower appliancedevice 516. Additionally, in certain embodiments, the positionerreceiver 564A can further including a locking mechanism 566 for lockingthe tongue positioner 560 in position. Alternatively, the positionerreceiver 564A can have another suitable design.

Additionally, in some embodiments, the appliance engager 564B caninclude a slot 567 with parallel and opposing sides that is configuredto slide over and slidably receive and engage the interior ridge of thereceiver extension 565, so that the appliance engager 564B iseffectively attached to the positioner receiver 564A. In certain suchembodiments, when the slot 567 of the appliance engager 564B slides overand is attached to the positioner receiver 564A, the appliance engager564B can include one or more engager extensions (not shown) within theslot 567 that engage the locking mechanism 566 such that the tonguepositioner 560 is securely, albeit removably, secured or coupled to thelower appliance member 516.

Further, in some embodiments, it is appreciated that the tonguepositioners 560 can be secured or coupled to the lower appliance member516, i.e. via the appliance engager 564B and the positioner receiver564A, in different orientations. For example, in certain suchembodiments, the tongue positioners 560 can be secured or coupled in anorientation that is angled between about forty-five degrees and sixtydegrees above a horizontal plane. Additionally, in some embodiments,this can be inverted, such that the tongue positioners 560 are securedor coupled in an orientation that is angled between about forty-fivedegrees and sixty degrees below a horizontal plane. Other angles arealso contemplated, and may be adjusted according to the anatomicalarrangements of the patient.

In various embodiments, with the positioner receiver 564A being part ofthe lower appliance member 516 and the appliance engager 564B being partof the tongue positioner 560, it is appreciated that the positionerreceiver 564A and the appliance engager 564B can be formed from anysuitable materials and/or can be formed from any suitable manufacturingprocess, similar to what was described above for the lower appliancemember 516 and the tongue positioner 560. For example, in somenon-exclusive embodiments, the positioner receiver 564A and theappliance engager 564B can be formed from a nylon-based material, e.g.,PA 2200 nylon, polyamide 12 nylon, or another suitable nylon material.Alternatively, the positioner receiver 564A and the appliance engager564B 564A, 564B can be formed from other suitable materials.

Additionally, in certain non-exclusive alternative embodiments, thepositioner receiver 564A and the appliance engager 564B can bemanufactured using one of a three-dimensional printer and a selectivelaser sintering process. Alternatively, the positioner receiver 564A andthe appliance engager 564B can be manufactured using another suitableprocess.

In summary, in various embodiments, different sizes, shapes, and typesof features for the tongue positioners 560 can be used, i.e. anyalternative tongue positioners 560 can be selectively and removablysecured to the lower appliance device 516, as can differentconfigurations for the positioner receiver 564A and the applianceengager 564B. These various embodiments provide healthcare professionalsand patients the ability to select tongue positioners 560 that arecomfortable, while providing optimal effectiveness for individualpatients with unique inferior dental arch anatomical structures.

FIG. 6A is a simplified front view illustration of a portion of yetanother embodiment of the oral appliance device 612. In particular, FIG.6A illustrates the oral appliance device 612 including the upperappliance member 614, and an embodiment of the jaw position controller626 that is used with the upper appliance member 614. The lowerappliance member is not illustrated in FIG. 6A for purposes of clarity,as the jaw position controller 626, as noted, is specifically useddirectly with the upper appliance member 614. However, it is appreciatedthat this embodiment of the oral appliance device 614 will alsotypically include the lower appliance member (e.g., the lower appliancemember 316 illustrated in FIG. 3A). More specifically, during use of theoral appliance device 612 within the mouth 10 (illustrated in FIG. 1),the jaw position controller 626 is typically positioned in a manner toengage the lower appliance member. Additionally, in certainnon-exclusive alternative embodiments, the oral appliance device 612 canfurther include one or more of the teeth spacing assembly 220(illustrated in FIG. 2A), the connector assembly 318 (illustrated inFIG. 3A), the nasal dilator assembly 422 (illustrated in FIG. 4A), thetongue positioner assembly 524 (illustrated in FIG. 5A), and the Herbstdevice assembly 728 (illustrated in FIG. 7A).

As with the other embodiments, during use of the oral appliance device612, the upper appliance member 614 is sized, shaped and positioned toselectively engage the upper teeth 11A (illustrated in FIG. 1). Asshown, the upper appliance member 614 can include a molding or castingof the patient's upper teeth 11A and a portion of surrounding oralgeography. The molding or casting of the upper teeth 11A can be taken inany suitable manner. For example, one type of molding can include takingimages of a patient's oral anatomy with a digital scanner or fromimpressions using a computer to map them before fabricating a molding.Additionally, in certain non-exclusive alternative embodiments, theupper appliance member 614 can then be manufactured using one of athree-dimensional printer and a selective laser sintering process.Intraoral scanners can allow patient information to be captured andstored in digital format before being transmitted or otherwise deliveredto the three-dimensional printer or the selective laser sintering devicefor fabrication. Further, it is appreciated that in embodiments thatalso include the lower appliance member, the lower appliance member canbe formed in a similar manner. Still further, it is also appreciatedthat in certain embodiments, the upper appliance member 614 (and thelower appliance member) can be formed from any suitable nylon-basedmaterials.

The jaw position controller 626 is configured to keep the lower jaw 17B(illustrated in FIG. 1) of the patient in a desired forward or backwardposition relative to the upper jaw 17A (illustrated in FIG. 1). Moreparticularly, similar to the connector assembly 318 and the Herbstdevice assembly 728, the jaw position controller 626 can function as ajaw positioner to inhibit the lower teeth 11B (illustrated in FIG. 1)and the lower jaw 17B from falling back in a supine position andpotentially blocking the upper airway of the patient.

The jaw position controller 626 can have any suitable design. In theembodiment illustrated in FIG. 6A, the jaw position controller 626includes a loop 626A (or ring) or partial loop that can be provided onand extend downward from an underside of the upper appliance member 614.In one embodiment, the jaw position controller 626 is integrally formedwith the upper appliance member 614. Alternatively, in anotherembodiment, the jaw position controller 626 can be formed separatelyfrom the upper appliance member 614 and be secured to the upperappliance member 614.

In some embodiments, the loop 626A of the jaw position controller 626can be formed by a length of material that has a cross-sectional profilethat is substantially circular. Additionally, the loop 626A can be bentsuch that it creates a u-shaped protuberance that extends downward at anangle from the upper appliance member 614. As such, when the oralappliance device 612 with the jaw position controller 626 is positionedin a patient's mouth, the loop 626A will rest just behind the lingualregion of the lower anterior teeth 11B. Further, in such embodiments,the loop 626A is generally large enough such that it gives space for thetongue 15 (illustrated in FIG. 1) to sit, as well as increase airflow.

The jaw position controller 626, i.e. the loop 626A, can be formed fromany suitable materials and can be formed in any suitable manner.Additionally, the jaw position controller 626 and/or the loop 626 can beformed so as to be flexible, semi-flexible, or rigid in certainalternative embodiments.

In certain embodiments, the jaw position controller 626 and/or the loop626A can be formed from materials that are substantially the same as thematerials utilized for the upper appliance member 614. Alternatively,the jaw position controller 626 and/or the loop 626A can be formed frommaterials that are different than the materials utilized for the upperappliance member 614. In some non-exclusive embodiments, the jawposition controller 626 and/or the loop 626A can be formed from anylon-based material, e.g., PA 2200 nylon, polyamide 12 nylon, oranother suitable nylon material. Alternatively, the jaw positioncontroller 626 and/or the loop 626A can be formed from other suitablematerials.

Additionally, in certain non-exclusive alternative embodiments, the jawposition controller 626 and/or the loop 626A can be manufactured usingone of a three-dimensional printer and a selective laser sinteringprocess. With such design, the jaw position controller 626 and/or theloop 626A can be quickly and easily made or remade from a single modelwithout the need for additional impressions or models. Alternatively,the jaw position controller 626 and/or the loop 626A can be manufacturedusing another suitable process.

FIGS. 6B and 6C provide alternative views of the portion of the oralappliance device 612 illustrated in FIG. 6A. In particular, FIG. 6B is atop perspective view illustration of the portion of the oral appliancedevice 612 illustrated in FIG. 6A; and FIG. 6C is a simplified side viewillustration of the portion of the oral appliance device 612 illustratedin FIG. 6A. As shown, FIGS. 6B and 6C illustrate certain additionalfeatures and/or details of the jaw position controller 626 that issecured or coupled to the upper appliance member 614. For example, FIG.6C more clearly illustrates how in certain embodiments the loop 626Aextends downward and rearward at an angle from the upper appliancemember 614. It is appreciated that the size of the loop 626A and theangle at which the loop 626A extends downward and rearward away from theupper appliance member 614 can be modified as desired to suit theparticular anatomy and requirements of the patient with whom the jawposition controller 626 is being used. Additionally, it is alsoappreciated that the size of the loop 626A and the angle at which theloop 626A extends downward and rearward away from the upper appliancemember 614 can be modified as desired to better enable the loop 626A toengage the lower appliance member during use within the mouth 10(illustrated in FIG. 1).

FIG. 7A is a simplified side view illustration of still yet anotherembodiment of the oral appliance device 712. More specifically, in theembodiment shown in FIG. 7A, the oral appliance device 712 includes anupper appliance member 714, a lower appliance member 716, and a Herbstdevice assembly 728 that selectively and movably couples the upperappliance member 714 and the lower appliance member 716. In certainnon-exclusive alternative embodiments, the oral appliance device 712 canfurther include one or more of the teeth spacing assembly 220(illustrated in FIG. 2A), the nasal dilator assembly 422 (illustrated inFIG. 4A), the tongue positioner assembly 524 (illustrated in FIG. 5A)and the jaw position controller 626 (illustrated in FIG. 6A).

As with the other embodiments, during use of the oral appliance device712, the upper appliance member 714 is positioned to selectively engagethe upper teeth 11A (illustrated in FIG. 1) and the lower appliancemember 716 is positioned to selectively engage the lower teeth 11B(illustrated in FIG. 1). As shown, the upper appliance member 714 caninclude a molding or casting of the patient's upper teeth 11A and aportion of surrounding oral geography. Similarly, the lower appliancemember 716 can include a molding or casting of the patient's lower teeth11B and a portion of surrounding oral geography. The molding or castingof the upper teeth 11A and the lower teeth 11B can be taken in anysuitable manner. For example, one type of molding can include takingimages of a patient's oral anatomy with a digital scanner or fromimpressions using a computer to map them before fabricating a molding.Additionally, in certain non-exclusive alternative embodiments, theappliance members 714, 716 can then be manufactured using one of athree-dimensional printer and a selective laser sintering process.Intraoral scanners can allow patient information to be captured andstored in digital format before being transmitted or otherwise deliveredto the three-dimensional printer or the selective laser sintering devicefor fabrication. Further, it is appreciated that in certain embodiments,the appliance members 714, 716 can be formed from any suitablenylon-based materials.

The Herbst device assembly 728 is configured to correct the bite, e.g.,an overbite, and/or correct jaw growth discrepancies of a patient. Morespecifically, in various embodiments, the Herbst device assembly 728 isconfigured to hold the lower jaw 17B (illustrated in FIG. 1) forwardand/or inhibit the lower jaw 17B from moving backward in a supineposition, and encourage the lower jaw 17B to grow and catch up with thesize of the upper jaw 17A (illustrated in FIG. 1) and face, therebyeliminating an overbite of the patient.

Additionally, the Herbst device assembly 728 is further configured tohelp inhibit the patient from snoring, while also assisting the patientin overcoming mild to moderate obstructive sleep apnea and/or othersleep-related issues. It is further appreciated that the Herbst deviceassembly 728 is also useful for addressing potential TMJ issues.

The design of the Herbst device assembly 728 can be varied to suit therequirements of the oral appliance device 712 and/or to meet thespecific anatomical requirements of the patient with whom the oralappliance device 712 is being used. In some embodiments, the Herbstdevice assembly 728 includes a first Herbst bar 770A, a second Herbstbar 770B that adjustably engages the first Herbst bar 770A, a firstHerbst connector assembly 772A that selectively and removably couplesthe first Herbst bar 770A to the upper appliance member 714 (e.g.,toward a front 714F of the upper appliance member 714), and a secondHerbst connector assembly 772B that selectively and removably couplesthe second Herbst bar 770B to the lower appliance member 716 (e.g.,toward a rear 716R of the lower appliance member 716). Alternatively,the Herbst device assembly 728 can include more components or fewercomponents than those specifically noted herein, and/or the Herbstdevice assembly 728 can have a different design than what is illustratedand described in detail herein.

As provided herein, the first Herbst bar 770A and the second Herbst bar770B are configured to adjustably engage one another to selectivelycontrol the positioning of the lower jaw 17B relative to the upper jaw17A, such as noted above. More particularly, the Herbst bars 770A, 770Bcan be set in position relative to one another to allow for a certaindegree of movement between the upper appliance member 714 and the lowerappliance member 716, and thus between the upper jaw 17A and the lowerjaw 17B. For example, in certain embodiments, the Herbst bars 770A, 770Bare adjustable relative to one another so as to allow betweenapproximately one millimeter and five millimeters of spacing and/orprotrusive titration between the upper appliance member 714 and thelower appliance member 716. When the Herbst bars 770A, 770B areinitially set in position relative to one another, the healthcareprofessional and/or the patient can evaluate whether or not the patientis receiving the desired relief. If the desired relief is not achieved,then the Herbst bars 770A, 770B can be moved relative to one another toanother suitable position and again be evaluated.

In the embodiment illustrated in FIG. 7A, the first Herbst bar 770A andthe second Herbst bar 770B are configured to engage one other in atelescoping manner. With such design, the Herbst bars 770A, 770B can beeasily moved relative to one another, e.g., in one-quarter millimeterincrements, to adjust the spacing and/or protrusive titration enabledbetween the upper appliance member 714 and the lower appliance member716. Alternatively, the Herbst bars 770A, 770B can be configured toadjustably engage one another in another suitable manner.

The Herbst bars 770A, 770B can be formed from any suitable materials.For example, in one non-exclusive embodiment, the Herbst bars 770A, 770Bcan be formed from stainless steel. Alternatively, in other embodiments,the Herbst bars 770A, 770B can be formed from other suitable materials.

Additionally, as noted above, the first Herbst connector assembly 772Ais configured to removably couple the first Herbst bar 770A to the upperappliance member 714. Similarly, the second Herbst connector assembly772B is configured to removably couple the second Herbst bar 770B to thelower appliance member 716. The Herbst connector assemblies 772A, 772Bcan have any suitable design. In many embodiments, the first Herbstconnector assembly 772A and the second Herbst connector assembly 772Bare substantially similar in design. Alternatively, the first Herbstconnector assembly 772A and the second Herbst connector assembly 772Bcan have a somewhat different design.

In various embodiments, the components of the Herbst connectorassemblies 772A, 772B can be formed from any suitable materials and/orcan be formed from any suitable manufacturing process. For example, insome non-exclusive embodiments, the components of the Herbst connectorassemblies 772A, 772B can be formed from a nylon-based material, e.g.,PA 2200 nylon, polyamide 12 nylon, or another suitable nylon material.Alternatively, the components of the Herbst connector assemblies 772A,772B can be formed from other suitable materials.

Additionally, in certain non-exclusive alternative embodiments, thecomponents of the Herbst connector assemblies 772A, 772B can bemanufactured using one of a three-dimensional printer and a selectivelaser sintering process. Alternatively, the components of the Herbstconnector assemblies 772A, 772B can be manufactured using anothersuitable process.

FIG. 7B is an exploded view illustration of a portion of the oralappliance device 712 illustrated in FIG. 7A. In particular, FIG. 7Billustrates an exploded view of an embodiment of the Herbst connectorassembly 772, e.g., which can be the first Herbst connector assembly772A and/or the second Herbst connector assembly 772B, and a portion ofone of the Herbst bars 770, e.g., the first Herbst bar 770A or thesecond Herbst bar 770B, of the Herbst device assembly 728 illustrated inFIG. 7A.

As noted above, the Herbst connector assembly 772 is configured forselectively and removably coupling the first Herbst bar 770A and thesecond Herbst bar 770B of the Herbst device assembly 728 to the upperappliance member 714 (illustrated in FIG. 7A) and the lower appliancemember 716 (illustrated in FIG. 7A) of the oral appliance device 712,respectively. The Herbst connector assembly 772 can have any suitabledesign. For example, in some embodiments, as shown in FIG. 7B, theHerbst connector assembly 772 can include a coupling base 774, acoupling insert 776, a coupling button 778, and a coupling pin 780.Alternatively, the Herbst connector assembly 772 can have morecomponents or fewer components than what is illustrated and describedherein. For example, in one non-exclusive alternative embodiment, theHerbst connector assembly 772 can be designed without the couplinginsert 776.

In certain embodiments, the coupling base 774 is secured to and/or isintegrally formed with one of the upper appliance member 714 and thelower appliance member 716. As shown, the coupling base 774 is somewhattruncated cone-shaped and includes a first base aperture 774A thatextends through a top of the coupling base 774 and that is configured toreceive at least a portion of the coupling insert 776 and at least aportion of the coupling button 778. Additionally, the coupling base 774further includes a pair of second base apertures 774B that extendthrough opposing sides of the coupling base 774. As described hereinbelow, the second base apertures 774B are configured to receive aportion of the coupling pin 780 when the Herbst bar 770 is beingeffectively secured or coupled to the appliance member 714, 716.

The coupling insert 776 is configured to be positioned substantiallywithin the coupling base 774 during use of the Herbst connector assembly772. As shown, the coupling insert 776 is generally annular-shaped andincludes a first insert aperture 776A that extends substantially fullythrough the coupling insert 776 and is configured to receive at least aportion of the coupling button 778. In certain embodiments, asillustrated, the first insert aperture 776A can be internally threadedto threadingly receive and retain a portion of the coupling button 778.Additionally, the coupling insert 776 further includes a pair of secondinsert apertures 776B that extend through opposing sides of the couplinginsert 776. As described herein below, the second insert apertures 776Bare configured to receive a portion of the coupling pin 780 when theHerbst bar 770 is being effectively secured or coupled to the appliancemember 714, 716.

The coupling button 778 is configured to be positioned at leastpartially within the coupling insert 776 and/or the coupling base 774during use of the Herbst coupling assembly 772. The design of thecoupling button 778 can be varied. As illustrated, the coupling button778 includes a button head 782 and a button shaft 784 that extends awayfrom the button head 782. Additionally, as shown, the button shaft 784can include external threads that are configured to threadingly engagethe internal threads of the first insert aperture 776A of the couplinginsert 776.

It is appreciated that in embodiments that do not include the couplinginsert 776, the coupling base 774 can include internal threads, and theexternal threads of the button shaft 784 can be configured tothreadingly engage the internal threads of the coupling base 774.

Additionally, as shown in FIG. 7B, a bar end 786 of the Herbst bar 770that is secured or coupled to the appliance member 714, 716 includes abar aperture 788.

During use of the Herbst device assembly 728, i.e. for purposes ofselectively and removably coupling the first Herbst bar 770A to theupper appliance member 714, and selectively and removably coupling thesecond Herbst bar 770B to the lower appliance member 716, the couplinginsert 776 is positioned substantially within the coupling base 774 thatis secured to the appliance member 714, 716, such that the second insertapertures 776B are aligned with the second base apertures 774B.Additionally, the coupling pin 780 is positioned to extend through bothof the second base apertures 774B and both of the second insertapertures 776B so that the coupling insert 776 can be effectivelyretained within the coupling base 774. The Herbst bar 770 is thenpositioned over the coupling insert 776 and/or the coupling base 774such that the bar aperture 788 is effectively aligned with the firstinsert aperture 776A and the first base aperture 774A. The button shaft784 is then extended through the bar aperture 788 of the Herbst bar 770and threaded into the first insert aperture 776A of the coupling insert776. Thus, the external threads of the button shaft 784 are positionedto threadingly engage the internal threads of the first insert aperture776A of the coupling insert 776. At this point, the Herbst bar 770 iseffectively, yet removably, secured or coupled to the appliance member714, 716 via the Herbst connector assembly 772.

It is understood that although a number of different embodiments of anoral appliance device have been illustrated and described herein, one ormore features of any one embodiment can be combined with one or morefeatures of one or more of the other embodiments, provided that suchcombination satisfies the intent of the present invention.

While a number of exemplary aspects and embodiments of the oralappliance device have been shown and disclosed herein above, those ofskill in the art will recognize certain modifications, permutations,additions and sub-combinations thereof. It is therefore intended thatthe present invention shall be interpreted to include all suchmodifications, permutations, additions and sub-combinations as arewithin their true spirit and scope, and no limitations are intended tothe details of construction or design herein shown.

What is claimed is:
 1. An oral appliance device for use within a humanmouth, the oral appliance device comprising: an upper appliance memberthat selectively engages upper teeth within the human mouth; a lowerappliance member that selectively engages lower teeth within the humanmouth, the appliance members being movable relative to one anotherbetween an open position and a closed position; and a first verticalshim that is removably secured to one of the appliance members, thefirst vertical shim having a first shim height so that a teeth spacingbetween the upper teeth and the lower teeth is maintained when theappliance members are in the closed position, the teeth spacing being atleast as great as the first shim height.
 2. The oral appliance device ofclaim 1 further comprising a second vertical shim that is alternatively,removably secured to one of the appliance members, the second verticalshim having a second shim height so that the teeth spacing between theupper teeth and the lower teeth is maintained when the appliance membersare in the closed position, the teeth spacing being at least as great asthe second shim height.
 3. The oral appliance device of claim 2 whereinthe first shim height is different than the second shim height.
 4. Theoral appliance device of claim 1 wherein the first vertical shim isremovably secured to the upper appliance member; and further comprisinga second vertical shim that is removably secured to the lower appliancemember, the second vertical shim having a second shim height so that theteeth spacing between the upper teeth and the lower teeth is maintainedwhen the appliance members are in the closed position, the teeth spacingbeing at least as great as the first shim height plus the second shimheight.
 5. The oral appliance device of claim 1 wherein the one of theappliance members includes a shim receiver that is configured toremovably receive and retain the first vertical shim.
 6. The oralappliance device of claim 5 wherein the first vertical shim includes anappliance engager that is integrally formed with the first verticalshim, and wherein the shim receiver is configured to removably receiveand retain the appliance engager of the vertical shim.
 7. The oralappliance device of claim 6 wherein the appliance engager rotatablyengages the shim receiver so that the first vertical shim is movablebetween a disengaged configuration wherein the first vertical shim isnot secured to the one of the appliance members, and an engagedconfiguration wherein the first vertical shim is secured to one of theappliance members.
 8. The oral appliance device of claim 6 wherein theappliance engager includes a post that extends away from a shim surfaceof the first vertical shim; and wherein the shim receiver includes anaperture formed into a member surface of the one of the appliancemembers, the aperture being sized and shaped to receive the post.
 9. Theoral appliance device of claim 1 wherein the first vertical shim isformed from a nylon-based material.
 10. The oral appliance device ofclaim 9 wherein the first vertical shim is manufactured using one of athree-dimensional printer and a selective laser sintering process. 11.The oral appliance device of claim 9 wherein the upper appliance memberand the lower appliance member are formed from a nylon-based material.12. The oral appliance device of claim 1 wherein the first vertical shimhas a first shim length, and further comprising a second vertical shimthat is alternatively, removably secured to one of the appliancemembers, the second vertical shim having a second shim length that isdifferent than the first shim length.
 13. The oral appliance device ofclaim 1 wherein the first vertical shim has a first shim width, andfurther comprising a second vertical shim that is alternatively,removably secured to one of the appliance members, the second verticalshim having a second shim width that is different than the first shimwidth.
 14. The oral appliance device of claim 1 further comprising asecond vertical shim that is removably secured to the appliance memberto which the first vertical shim is removably secured, the secondvertical shim having a second shim height that is substantially the sameas the first shim height.
 15. An oral appliance device for use within ahuman mouth, the oral appliance device comprising: an upper appliancemember that selectively engages upper teeth within the human mouth; alower appliance member that selectively engages lower teeth within thehuman mouth; a first vertical shim that is removably secured to one ofthe appliance members, the first vertical shim having a first shimheight; and a second vertical shim that is alternatively, removablysecured to the one of the appliance members, the second vertical shimhaving a second shim height that is different than the first shimheight.
 16. The oral appliance device of claim 15 wherein the firstvertical shim is removably secured to the upper appliance member; andthe second vertical shim is removably secured to the lower appliancemember.
 17. The oral appliance device of claim 15 wherein the one of theappliance members includes a shim receiver that is configured toalternatively, removably receive and retain the first vertical shim andthe second vertical shim.
 18. The oral appliance device of claim 17wherein the first vertical shim and the second vertical shim eachincludes an appliance engager, and wherein the shim receiver isconfigured to alternatively, removably receive and retain the applianceengager of the first vertical shim and the second appliance engager ofthe second vertical shim.
 19. The oral appliance device of claim 15wherein at least one of vertical shims is formed from a nylon-basedmaterial.
 20. The oral appliance device of claim 19 wherein at least oneof the vertical shims is manufactured using one of a three-dimensionalprinter and a selective laser sintering process.